Frailty Assessment in eldeRly Admitted to hoSpital for acutE caRdiac Disease Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 402
- 试验地点
- 2
- 主要终点
- composite endpoint of all-cause mortality and all-cause hospital admission
研究概览
简要总结
In Italy, life expectancy at birth has reached 80 years in men and 85 in women; in about 50 years, life expectancy at the age of 80 has increased by an extraordinary 61% and 55%, respectively, due to more effective therapies and lower mortality of many diseases. Yet, chronic diseases are nowadays more important, and often coexist as comorbidity or multimorbidity, depending on whether an index condition has been considered. These conditions increase the risk of death and reduce functional autonomy in the elderly and, therefore, should be carefully considered within comprehensive geriatric assessment. The epidemiology of cardiovascular disease, as demonstrated among others by the Oxford Vascular Study, shows a clear trend in age-dependent, as the number of events and their incidence increases with age, and about half are concentrates over 75 years.
In addition, some observational studies in elderly patients have suggested an association between frailty and cardiovascular disease: fragility and cardiovascular disease share a common biological pathway, and cardiovascular diseases may accelerate the onset of frailty. The frailty syndrome was identified in 25% to 50% of patients with cardiovascular disease, according to the rating scale used and the population studied. Frail patients with cardiovascular disease, in particular those undergoing invasive procedures or suffering from coronary artery disease and aortic valve disease, have a much higher adverse events and complications, suggesting the need for a more accurate functional stratification and a more careful evaluation of the risk/benefit ratio of some invasive procedures.
Among the numerous tests proposed in the literature for the functional evaluation and objective measures of physical capability in elderly patient, the Short Physical Performance Battery (SPPB) and the evaluation of hand grip strength (grip strength) are those characterized by an improved prognostic ability and an easy administration.
The present study is performed to assess if SPPB and handgrip are helpful to better stratify the prognosis (all-causes death and hospital admission for all causes) in elderly patients admitted to hospital for cardiac causes.
详细描述
This is a prospective observational study. This a multicenter study involving 4 Italian Cardiology Units (Ferrara, Cento, Forlì, Ravenna).
The study is expected to enroll at least 400 consecutive patients with ≥70 years, which are admitted to our cardiovascular departement for:
- GROUP A: acute coronary syndrome,
- GROUP B: bradycardia or tachyarrhythmias requiring device implantation (pace-maker, implantable cardioverter defibrillator, cardiac resynchronization therapy)
- GROUP C: acute heart failure.
- GROUP D: symptomatic severe aortic stenosis receiving aortic valve replacement or aortic balloon valvuloplasty or transcatheter aortic valve implantation.
The main group of the study is the group A. The Authors will enroll at least 300 patients of the group A. The main finding of the study will be for ACS patients. The results of group A will be reported by Authors in a separate and principal paper.
To generate hypothesis for future studies, the Authors will enroll also other groups of patients admitted to hospital for cardiac cause (group B, C and D). These patients will be object of separate publications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hospital admission in the cardiac department for acute cardiac disease (acute coronary syndromes, acute heart failure, arrhythmias requiring pace-maker or implantable cardioverter-defibrillator)
排除标准
- •SPMSQ value ≤4
- •inability to stay upright
- •life expectancy <3 months
结局指标
主要结局
composite endpoint of all-cause mortality and all-cause hospital admission
时间窗: 1 year
1-year cumulative incidence of all-cause mortality and all-cause hospital admission
次要结局
- cardiac adverse events(1 year)
- all-cause mortality(1 year)
- hospital admission for all-causes(1 year)
研究者
Gianluca Campo
MD
University Hospital of Ferrara